Zhejiang Huahai Pharmaceutical Co., Ltd.
Form 483 issued November 20, 2024 · Linhai, China
- Inspection
- Nov 12 – Nov 20, 2024
- Investigators
- Alan A. Rivera· Pratik S. Upadhyay
- Observations
- 8
- Pages
- 11
- FEI number
- 3003885745
In short: On November 20, 2024, FDA issued a Form 483 with 8 observations to Zhejiang Huahai Pharmaceutical Co., Ltd. in Linhai, Zhejiang (FEI 3003885745) after an inspection that ran Nov 12 – Nov 20, 2024. The investigators were Alan A. Rivera and Pratik S. Upadhyay. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete test data…
- 02
Deviations from analytical test…
- 03
Laboratory investigations are not adequately conducted to…
- 04
Deviation investigation relating to facility, equipment and production…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmZhejiang Huahai Pharmaceutical Co., Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zhejiang Huahai Pharmaceutical Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zhejiang Huahai Pharmaceutical Co., Ltd.?
Alan A. Rivera and Pratik S. Upadhyay are named on this Form 483, for the inspection of Nov 12 – Nov 20, 2024. Each investigator has a profile showing what they cite most.
When was Zhejiang Huahai Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Nov 12 – Nov 20, 2024, and the Form 483 is dated November 20, 2024.
How do I get the full Form 483 for Zhejiang Huahai Pharmaceutical Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.